Scheriproct 1.5mg/g + 5mg/g rectal ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PREDNISOLONE CAPROATE; Cinchocaine hydrochloride

Available from:

KARO PHARMA AB

ATC code:

C05AA; C05AA04

INN (International Name):

PREDNISOLONE CAPROATE; Cinchocaine hydrochloride

Dosage:

1.5mg/g + 5 milligram(s)/gram

Pharmaceutical form:

Rectal ointment

Therapeutic area:

Corticosteroids; prednisolone

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

PATIENT INFORMATION
LEAFLET
SCHERIPROCT
® 1.5 MG/G +
5
MG/G RECTAL OINTMENT
SCHERIPROCT
® 1 MG + 1 MG
SUPPOSITORIES
PREDNISOLONE, CINCHOCAINE
HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need
to read it again.

If you have any further questions,
ask your doctor or pharmacist.

This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of illness
are the same as yours.

If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not mentioned in this leaflet. See
section 4.
IN THIS LEAFLET:
1.
WHAT SCHERIPROCT
® IS AND WHAT
IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU USE SCHERIPROCT
®
3.
HOW TO USE SCHERIPROCT
®
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SCHERIPROCT
®
6.
CONTENTS OF THE PACK AND
FURTHER INFORMATION
1.
WHAT SCHERIPROCT
® IS AND WHAT
IT IS USED FOR
Scheriproct contains a substance
which reduces inflammation
(prednisolone), and a local
anaesthetic (cinchocaine) which
relieves pain.
This medicine is used for the relief of
the inflammation, swelling, itching and
soreness of piles (haemorrhoids) and
to relieve itching of the anus (back
passage). It is used short-term usually
for 5 to 7 days.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU USE SCHERIPROCT
®
DO NOT USE SCHERIPROCT IF YOU:

are allergic (hypersensitive) to
prednisolone caproate, cinchocaine
hydrochloride, other local
anaesthetics or any of the other
ingredients of Scheriproct.

have a viral infection (e.g. herpes,
shingles, chicken-pox)

have any bacterial or fungal
infections of the skin for which you are
not receiving treatment
WARNINGS AND PRECAUTIONS

Talk to your doctor, pharmacist or
nurse before using Scheriproct in
the following cases: Long-term
continuous treatment should be
avoided because it can cause the
skin to thin and deteriorate in the
affected area (see section 4.
“Possible Side E

Summary of Product characteristics

Health Products Regulatory Authority
25 May 2021
CRN00C52N
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Scheriproct 1.5mg/g + 5mg/g rectal ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of ointment contains prednisolone caproate equivalent to 1.5 mg of
prednisolone and 5 mg of cinchocaine hydrochloride.
EXCIPIENTS WITH KNOWN EFFECT:
1 g of ointment contains 442.9 mg castor oil refined, 75 mg castor oil
hydrogenated, 75 mg macrogol 400 monoricinoleate and
0.2 mg perfume oil, chypre (see section 4.4).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal ointment
Colourless to faintly yellow homogeneous translucent ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of symptoms of internal or external haemorrhoids,
anal fissures and proctitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The anal region should be cleaned thoroughly before using Scheriproct,
which is best applied after defaecation.
Usual application twice daily. On the first day, for faster
symptomatic relief, up to four times. Protruding lumps should be
smeared and carefully pressed back with the finger.
Duration of treatment should not usually exceed 1 week. Specific
treatment of the condition giving rise to the haemorrhoids
may be required.
Before applying within the rectum, the enclosed applicator should be
screwed onto the tube (for use and cleaning of the
applicator see section 6.6).
4.3 CONTRAINDICATIONS
Use in the presence of untreated infections of bacterial, viral,
tuberculous or fungal origin.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Additional specific therapy is required in bacterial and/or fungal
infections.
There have been a few reports in the literature of the development of
cataracts in patients who have been using corticosteroids
for prolonged periods of time. Although it is not possible to rule out
systemic corticosteroids as a known factor, prescribers
should be aware of the possible role of corticosteroids in cataract
development.
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